MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER; CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number H21911

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The (b)(4) case study and logs were returned for evaluation.Review indicated pacing, with synchronization turned on, was attempted during the time period in which the patient developed asystole.In order to deliver pacing when the patient experiences asystole, synchronization must be disabled.The logs indicated synchronization was then disabled to continue the procedure.

Event Description

During an atrial flutter ablation procedure the patient experienced asystole for seven seconds.It was reported the sync mode may have been inadvertently selected resulting in the event.The patient did not require any intervention to treat the asystole and the procedure was then completed successfully with the patient in stable condition.

• Brand Name: EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER
• Type of Device: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5633751
• MDR Text Key: 44475740
• Report Number: 2184149-2016-00002
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H21911
• Device Lot Number: 5026002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 110